Administration System, Delivery Device, and Notification Device for Communicating Status of a Medical Device

ABSTRACT

An administration system for delivery of a pharmaceutical composition to a patient has a delivery device configured to deliver a dose of the pharmaceutical composition to the patient and a notification device in communication with the delivery device. The notification device is configured to communicate information about a status of at least one property of the delivery device. The delivery device can be a wearable automatic injector configured to be worn on the patient&#39;s skin. The delivery device of the present disclosure may allow a user or the patient to view a status of a container. For example, the delivery device of the present disclosure may provide a simple and effective visual means of displaying fill confirmation and delivery confirmation.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 16/038,626 entitled “Administration System, Delivery Device,and Notification Device for Communicating Status of a Medical Device”filed Jul. 18, 2018, which claims priority to U.S. ProvisionalApplication Ser. No. 62/533,954 entitled “Notification Device forCommunicating Status of a Medical Device” filed Jul. 18, 2017; U.S.Provisional Application Ser. No. 62/559,051 entitled “NotificationDevice for Communicating Status of a Medical Device” filed Sep. 15,2017; and U.S. Provisional Application Ser. No. 62/626,935 entitled“Administration System, Delivery Device, and Notification Device forCommunicating Status of a Medical Device” filed Feb. 6, 2018, the entiredisclosures of each of which are hereby incorporated by reference.

BACKGROUND OF THE INVENTION Field of the Invention

The present disclosure relates generally to devices, systems, andmethods for the delivery of pharmaceutical compositions to a patient.More particularly, the present disclosure relates to devices, systems,and methods for the delivery of pharmaceutical compositions to a patientusing an automatic injector and to a notification device forcommunicating at least one property of the automatic injector, and todevices allowing a patient to view the status of a container such as avisual means of displaying fill confirmation and/or deliveryconfirmation.

Description of Related Art

Wearable medical devices, such as automatic injectors, have the benefitof providing therapy to the patient at a location remote from a clinicalfacility and/or while being worn discretely under the patient'sclothing. On a physician's determination, the wearable medical devicecan be applied to the patient's skin and configured to automaticallydeliver a dose of the pharmaceutical composition within a predeterminedtime period after applying the wearable medical device to the patient'sskin, such as after a 27 hour delay. After the device delivers thepharmaceutical composition to the patient, the patient may subsequentlyremove and dispose of the device.

Some wearable medical devices have the capability of communicating atleast one property of the device to the patient. For example, somedevices may provide a direct on-device visual, audible, or tactilefeedback to the patient to inform the patient about the state of thedevice, such as when the device is delivering the pharmaceuticalcomposition to the patient or when the delivery procedure is completed.While existing devices provide discreteness, one drawback of this isthat any visual, audible, or tactile feedback of the device cannot beeasily communicated to the patient because the device is obstructed bythe patient's clothing or by the placement of the device on a particularlocation on the patient's body. For example, notifications issued by thedevice have limited visibility when the device is placed on the back ofthe patient's arm, often requiring a caregiver to observe thenotifications. Additionally, in cases when the device is worn on thepatient's abdomen, the device is obstructed by the patient's clothingand cannot be easily checked without removing the patient's clothing.

Accordingly, there is a need in the art for the delivery ofpharmaceutical compositions to a patient using an automatic injector andto a notification device for communicating at least one property of theautomatic injector.

SUMMARY OF THE INVENTION

The present disclosure provides for the device for the delivery ofpharmaceutical compositions to a patient using an automatic injector andto a notification device for communicating at least one property of theautomatic injector.

In some examples, an administration system for delivery of apharmaceutical composition to a patient may have a delivery deviceconfigured to deliver a dose of the pharmaceutical composition to thepatient and a notification device in communication with the deliverydevice. The notification device may be configured to communicateinformation about a status of at least one property of the deliverydevice. The delivery device may be a wearable automatic injectorconfigured to be worn on the patient's skin. The notification device mayhave at least one indicator. The at least one indicator may be a visualindicator, an audible indicator, a tactile indicator, or a combinationthereof. The notification device may be a wristband. The at least oneproperty of the delivery device may include a delivery status of thedelivery device.

In accordance with an embodiment of the present invention, a deliveryapparatus is configured to deliver a dose of a medicament to a patient.The delivery system includes a delivery device having a housingincluding a viewing window, a flexible container disposed within thehousing and for storing the medicament therein, and a visual identifieraligned with a portion of the viewing window, wherein a position of thevisual identifier relative to the viewing window is dependent on avolume of the medicament within the container. The delivery apparatusalso includes a notification device in communication with the deliverydevice, the notification device configured to communicate informationabout a status of at least one property of the delivery device.

In another configuration, the visual identifier is movable relative tothe viewing window between an empty position, in which the container isempty, and a full position, in which the container is full. The visualidentifier may include a connector that is attachable to a portion ofthe container. The connector may be attachable to a sealed edge of thecontainer, and the connector may include an indicator clip.

The visual identifier may be disposed within the housing between thecontainer and a deformable material. As the container is filled with themedicament, the container expands and moves the visual identifierdownward thereby compressing the deformable material. As the containerdelivers the medicament, the container shrinks and the deformablematerial expands thereby moving the visual identifier upward.Optionally, the deformable material comprises a foam.

In certain configurations, the visual identifier includes a deflectablemember. As the container is filled with the medicament, the containerexpands and deflects one end of the deflectable member downward. As thecontainer delivers the medicament, the container shrinks and the one endof the deflectable member returns to its original position. The housingmay include a fill-indicator display adjacent the viewing window. Thevisual identifier may align with a portion of the fill-indicator displayto identify an amount of medicament within the container. The containermay be a reservoir bag and the visual identifier may be a portion of thereservoir bag.

In certain configurations, the viewing window is located in a sidewallof the housing. The delivery device may be a wearable automatic injectorremovably attachable to a skin surface of the patient. Optionally, thedelivery device includes at least one indicator for communicating acondition of the delivery device to the patient. The notification devicemay be a wristband, and the notification device may be in passiveone-way communication with the delivery device and wherein thenotification device displays a status of at least one property of thedelivery device.

In accordance with another embodiment of the present invention, anadministration system for delivery of a pharmaceutical composition to apatient includes a delivery device configured to deliver a dose of thepharmaceutical composition to the patient, and a notification device incommunication with the delivery device, the notification deviceconfigured to communicate information about a status of at least oneproperty of the delivery device. The notification device is in passiveone-way communication with the delivery device, and the notificationdevice displays a status of at least one property of the deliverydevice.

In certain configurations, the delivery device is a wearable automaticinjector configured to be worn on the patient's skin. The notificationdevice may include at least one indicator. The at least one indicatormay be a visual indicator, an audible indicator, a tactile indicator, ora combination thereof. Optionally, the notification device is awristband and the at least one property of the delivery device comprisesa delivery status of the delivery device. The delivery device mayinclude a reservoir bag configured to contain a medicament therein andthe reservoir bag may include a visual identifier. The delivery devicemay further include a fill-indicator display, and the visual identifierof the reservoir bag is configured to align with a portion of thefill-indicator display depending on the volume of medicament disposedwithin the reservoir bag. Optionally, the delivery device furtherincludes at least one indicator capable of communicating a condition ofthe delivery device to a user, wherein the indicator may be an LED.

These and other features and characteristics of an administration systemand methods of using the same will become more apparent uponconsideration of the following description and the appended claims withreference to the accompanying drawings, all of which form a part of thisspecification, wherein like reference numerals designate correspondingparts in the various drawings. It is to be expressly understood,however, that the drawings are for the purpose of illustration anddescription only.

BRIEF DESCRIPTION OF THE DRAWINGS

The above-mentioned and other features and advantages of thisdisclosure, and the manner of attaining them, will become more apparentand the disclosure itself will be better understood by reference to thefollowing descriptions of embodiments of the disclosure taken inconjunction with the accompanying drawings, wherein:

FIG. 1 is a perspective view of a wearable automatic injector and anotification device paired to the wearable automatic injector inaccordance with an embodiment of the present invention;

FIG. 2 is a perspective top view of a wearable automatic injector inaccordance with an embodiment of the present invention;

FIG. 3 is a top view of a wearable automatic injector in accordance withan embodiment of the present invention;

FIG. 4 is a perspective view of a notification device for use with awearable automatic injector in accordance with an embodiment of thepresent invention;

FIG. 5A is a top view of a display of a notification device for use witha wearable automatic injector showing an initial pre-use state inaccordance with an embodiment of the present invention;

FIG. 5B is a top view of a display of a notification device for use witha wearable automatic injector showing a state of indication after afirst period of time has elapsed after initiation in accordance with anembodiment of the present invention;

FIG. 5C is a top view of a display of a notification device for use witha wearable automatic injector showing a state of indication after asecond period of time has elapsed after initiation in accordance with anembodiment of the present invention;

FIG. 5D is a top view of a display of a notification device for use witha wearable automatic injector showing a state of indication after athird period of time has elapsed after initiation in accordance with anembodiment of the present invention;

FIG. 6A is a perspective view of a user preparing the wearable automaticinjector for attachment to a patient's skin in accordance with anembodiment of the present invention;

FIG. 6B is a perspective view of a user preparing the wearable automaticinjector for attachment to a patient's skin in accordance with anembodiment of the present invention;

FIG. 6C is a top view of the wearable automatic injector as applied tothe patient's skin and signaling activation of the device in accordancewith an embodiment of the present invention;

FIG. 6D is a top view of the wearable automatic injector in an activatedstate in accordance with an embodiment of the present invention;

FIGS. 7A-7B are schematic representations of a life cycle of a wearableautomatic injector and notification device in accordance with anembodiment of the present invention;

FIGS. 8A-8B are schematic representations of workflow for use of awearable automatic injector and a notification device in accordance withan embodiment of the present invention;

FIG. 9 is a schematic representation of a communication link between awearable automatic injector and a notification device in accordance withan embodiment of the present invention;

FIG. 10A is a schematic side view of a wearable automatic injectorhaving a fill-indicator display in the prior to filling/empty conditionin accordance with an embodiment of the present invention, the deliveryneedle is shown in an extended position for representation of the deviceonly, and it is intended that the device may not include an extendeddelivery needle during the filling process;

FIG. 10B is a schematic side view of a wearable automatic injectorhaving a fill-indicator display in the partially filled/deliveredcondition in accordance with an embodiment of the present invention, thedelivery needle is shown in an extended position for representation ofthe device only, and it is intended that the device may not include anextended delivery needle during the filling process;

FIG. 10C is a schematic side view of a wearable automatic injectorhaving a fill-indicator display in the filled condition in accordancewith an embodiment of the present invention, the delivery needle isshown in an extended position for representation of the device only, andit is intended that the device may not include an extended deliveryneedle during the filling process;

FIGS. 11-12 are perspective views of a wearable automatic injectorhaving a fill-indicator display and a separate LED indicator inaccordance with an embodiment of the present invention;

FIG. 13 is a side view of a wearable automatic injector having a viewingwindow with a visual identifier aligned within the viewing window in afull position in accordance with an embodiment of the present invention;

FIG. 14 is a side view of a wearable automatic injector having a viewingwindow with a visual identifier aligned within the viewing window in anempty position in accordance with an embodiment of the presentinvention;

FIG. 15 is a cross-sectional front view of a wearable automatic injectorhousing with a visual identifier connector that is attachable to aportion of a medicament container, with the visual identifier in anempty position and aligned within the viewing window, in accordance withan embodiment of the present invention;

FIG. 16 is a perspective view of a medicament container for receiptwithin a wearable automatic injector, the medicament container having avisual identifier attachable thereto in accordance with an embodiment ofthe present invention;

FIG. 17 is a cross-sectional front view of a wearable automatic injectorhousing with a visual identifier connector that is attachable to aportion of a medicament container, with the visual identifier in afilled position and aligned within the viewing window, in accordancewith an embodiment of the present invention;

FIG. 18 is a cross-sectional front view of a wearable automatic injectorhousing with a visual identifier and a deformable material, with thevisual identifier in an empty position, in accordance with an embodimentof the present invention;

FIG. 19 is a cross-sectional front view of a wearable automatic injectorhousing with a visual identifier and a deformable material, with thevisual identifier in a filled position and the deformable material in acompressed position, in accordance with an embodiment of the presentinvention;

FIG. 20 is a cross-sectional front view of a wearable automatic injectorhousing with a visual identifier including a deflectable member, withthe visual identifier in an empty position, in accordance with anembodiment of the present invention;

FIG. 21 is a cross-sectional front view of a wearable automatic injectorhousing with a visual identifier including a deflectable member, withthe visual identifier in a filled position, in accordance with anembodiment of the present invention;

FIG. 22 is an exploded perspective view of a medicament container and adeflectable member in accordance with an embodiment of the presentinvention; and

FIG. 23 is an assembled perspective view of a medicament container and adeflectable member in accordance with an embodiment of the presentinvention.

Corresponding reference characters indicate corresponding partsthroughout the several views. The exemplifications set out hereinillustrate exemplary embodiments of the disclosure, and suchexemplifications are not to be construed as limiting the scope of thedisclosure in any manner.

DETAILED DESCRIPTION OF THE INVENTION

Spatial or directional terms, such as “left”, “right”, “inner”, “outer”,“above”, “below”, and the like, are not to be considered as limiting asthe invention can assume various alternative orientations.

All numbers used in the specification and claims are to be understood asbeing modified in all instances by the term “about”. By “about” is meanta range of plus or minus ten percent of the stated value. As used in thespecification and the claims, the singular form of “a”, “an”, and “the”include plural referents unless the context clearly dictates otherwise.

The terms “first”, “second”, and the like are not intended to refer toany particular order or chronology, but instead refer to differentconditions, properties, or elements. By “at least” is meant “greaterthan or equal to”. By “not greater than” is meant “less than or equalto”.

Administration System

With reference to FIG. 1 , an administration system 10 for delivery of apharmaceutical composition, e.g., any desired medicament or therapeuticagent, to a patient may have a delivery device 20, such as a wearableautomatic injector, configured to deliver a dose of the pharmaceuticalcomposition to the patient and a notification device 30 in communicationwith the delivery device 20. The notification device 30 may beconfigured to communicate information about a status of at least oneproperty of the delivery device 20.

In some examples, the notification device 30 may be in wirelesselectronic communication with the delivery device 20. In other examples,the notification device 30 may be in wired electronic communication withthe delivery device 20. In some examples where the notification device30 and the delivery device 20 are wirelessly connected, the notificationdevice 30 may be configured for passive one-way communication with thedelivery device 20 wherein the notification device 30 is configured tocommunicate information about a status of at least one property of thedelivery device 20 without controlling any aspect of the delivery device20. In other examples where the notification device 30 and the deliverydevice 20 are wirelessly connected, the notification device 30 may beconfigured for two-way communication with the delivery device 20 whereinthe notification device 30 is configured to communicate informationabout a status of at least one property of the delivery device 20 and tocontrol at least one aspect of the delivery device 20, such asactivation, reset functions, and the like.

The notification device 30 may have at least one indicator. The at leastone indicator may be a visual indicator, an audible indicator, a tactileindicator, or a combination thereof. The delivery device 20 and/or thenotification device 30 may be disposable after a dose of thepharmaceutical composition is delivered to the patient. In someexamples, the delivery device 20 may be disposable after a dose of thepharmaceutical composition is delivered to the patient, while thenotification device 30 may be reusable with another delivery device 20.

Delivery Device

With reference to FIGS. 2-3 , the delivery device 20 may be, in someexamples, a wearable automatic injector, such as an insulin or bonemarrow stimulant delivery device. In use, the delivery device 20containing a pharmaceutical composition, e.g., any desired medicament,is mounted onto the skin of a patient and triggered to inject thepharmaceutical composition into the patient. The delivery device 20 maybe pre-filled with the pharmaceutical composition, or it may be filledwith the pharmaceutical composition by the patient or medicalprofessional prior to use.

The delivery device 20 is configured to deliver a dose of apharmaceutical composition, e.g., any desired medicament, into thepatient's body by a subcutaneous injection at a slow, controlledinjection rate. Exemplary time durations for the delivery achieved bythe delivery device 20 may range from about 5 minutes to about 60minutes, but are not limited to this exemplary range. Exemplary volumesof the pharmaceutical composition delivered by the delivery device 20may range from about 0.1 milliliters to about 10 milliliters, but arenot limited to this exemplary range. The volume of the pharmaceuticalcomposition delivered to the patient may be adjusted.

With continued reference to FIGS. 2-3 , the delivery device 20 has ahousing 40 comprising a dermal pad 50 securable to the patient's skin.The dermal pad 50 may have an adhesive for adhesively connecting thedelivery device 20 to the patient's skin. The housing 40 has aninjection assembly (not shown) moveably disposed in the housing 40. Theinjection assembly has a hypodermic injection needle 60 (shown in FIG.6B) for insertion into the patient. The injection assembly is configuredfor moving the injection needle 60 between a retracted position, inwhich the injection needle 60 does not protrude outside the housing 40,and an extended position, in which the injection needle 60 protrudesoutside the housing 40 and through the dermal pad 50 such that theinjection needle 60 can be inserted into the patient's body. Theinjection needle 60 may be retractable from the extended position to theretracted position after the pharmaceutical composition is delivered tothe patient and prior to removal of the delivery device 20 from thepatient's body. A window 65, or other indicator, may be provided on thehousing 40 for visualizing the injection needle 60.

With continued reference to FIGS. 2-3 , the delivery device 20 has aninternal medicament container, such as a reservoir bag 306 (shown inFIG. 15 ) provided in the housing 40 for holding a volume of themedicament or therapeutic agent. The medicament or therapeutic agent maybe delivered from the container through the injection needle 60 by adelivery mechanism of the injection assembly.

The delivery device 20 of the present disclosure allows a user orpatient to view the status of the internal medicament container 306. Forexample, a delivery device of the present disclosure provides a simpleand effective visual means of displaying fill confirmation and/ordelivery confirmation. Referring to FIGS. 13-23 , in exemplaryembodiments, a delivery device 300 of the present disclosure isconfigured to deliver a dose of a medicament to a patient or user. Thedelivery device 300 generally includes a housing 302 including a viewingwindow 304, a medicament container 306, such as a reservoir bag,disposed within the housing 302 and for storing the medicament ortherapeutic agent therein, and a visual identifier 308 aligned with aportion of the viewing window 304, wherein a position of the visualidentifier 308 relative to the viewing window 304 is dependent on avolume of the medicament within the container 306.

In this manner, a user of the delivery device is able to easily view thestatus of a container 306. For example, a technician is able to easilydetermine if any medicament is stored within the container 306, how muchmedicament is stored within the container 306, if the container 306 isempty and needs to be filled with a medicament, and/or if the container306 is full of a medicament and ready to be used by a patient, or if themedicament has been fully delivered from the container 306 into thepatient.

Referring to FIGS. 10A-10C and FIGS. 15-21 , in one embodiment, acontainer 306 includes at least one expandable portion 290 which is atleast partially visible through a viewing window 280 disposed in atleast a portion of the housing of the delivery device 20. In certainconfigurations, the entire container 306 may be expandable. For example,the container 306 may be made from a flexible material which expands insize as a fluid medicament is filled into the container 306. Optionally,the container 306 may have a visual indicator integrally formedtherewith. In one embodiment, the container 306 may be made of amaterial having a visually distinct color, such as a fluorescent greenmaterial, such that the positioning of the container 306 within theviewing window 280 is readily identifiable. In this manner, when thecontainer 306 is empty, a color band of the reservoir bag 290 beingshown through the viewing window 280 appears to be a straight or nearstraight line located adjacent an empty indicator line. Also, as thecontainer 306 is filled and expands, the width of the container 306 isincreased thereby a color band of the container 306 being shown throughthe viewing window 280 appears to be a broad, wide band that expands toa point adjacent a full indicator line. In other configurations, thecolor band of the reservoir bag 290 may be provided in a first positionwithin the viewing window 280 in an empty position, and may be providedin a second position within the viewing window 280 in a full position.

In other configurations, a visual identifier may be stamped or paintedonto at least a portion of the container 306. The visual identifier maybe in the form of a line or other distinct patterning, alternatively,the entire container 306 may include the visual identifier, such as anoverall color of the container 306.

In one embodiment, a color band may be added to the container 306 by padprinting, roll printing, adhesive patch attachment, or other similarprocess. In one embodiment, a window may be added to a top cover of thedelivery device 20 to allow visual sight to a colored edge of thecontainer 306. In one embodiment, this is done by over printing or overlabeling onto a clear top cover obscuring some regions of the top coverand allowing see through windows in other regions of the cover,multi-shot molding to create clear and opaque regions in the top cover,molding an opaque cover with a hole where the window is desired andincorporating a clear window part as a post processing step. It is alsoenvisioned to create an opaque top cover without a window and throughpost processing steps cut a hole where the window is desired and then awindow may be added to that location.

In one embodiment, the container 306 may be made of a material having avisually distinct color. For example, particular colors may be moreadvantageous and increase the viewability of the state and/or conditionof the container 306. Also, the addition of lighting inside or outsideof the system can be used to increase viewability. The window area maybe reticulated to aid in the distinction between filled and unfilledstates of the container 306.

In one embodiment, the entire container 306, or significant portions ofthe container 306, may be made of a material having a visually distinctcolor, such as a fluorescent green material, such that the positioningof the container 306, such as a reservoir bag, within the viewing window280 is readily identifiable. In other configurations, a visualidentifier 308 may be stamped or painted onto at least a portion of thecontainer 306. The visual identifier 308 may be in the form of a line orother distinct patterning, alternatively, the entire container 306 mayinclude the visual identifier 308, such as an overall color of thecontainer 306. Depending on the particular nature of the medicament tobe provided into the container 306, it may be desirable to provide acontainer 306 that is light-impermeable.

Referring to FIGS. 13 and 14 , a separate visual identifier 308 of thepresent disclosure is movable relative to the viewing window 304 of ahousing 302 of a delivery device 300 between an empty position (FIG. 14), in which the container 306 is empty, and a full position (FIG. 13 ),in which the container 306 is full. Referring to FIGS. 13 and 14 , inone embodiment, as the container 306 is filled, the container 306expands. In one embodiment, because the top of the container 306 isconstrained by the top of the housing 302, e.g., as shown in FIGS. 15and 17 , the container 306 is forced to expand downward as it is filled.As the container 306 is forced in a downward direction, the separatevisual identifier 308 may also be forced in a downward direction by theweight of the container 306 to transition the visual identifier 308 froma first position to a second position, indicative of the amount ofmedicament within the container 306. It is noted herein that thepositioning of the visual identifier 308 may transition during bothfilling and also during delivery of the medicament. In thisconfiguration, as the weight of the container 306 lessens as thecontents of the container 306 are delivered to a patient, the visualidentifier 308 may transition from a first position to a second positionin an upward direction.

Referring to FIGS. 13 and 14 , in one embodiment, the viewing window 304is located in a sidewall of the housing 302. Referring to FIG. 3 , inother embodiments, a viewing window 200 may be located in a top wall ofa housing 40 of a delivery device 20. In other alternative embodiments,the viewing window of the present disclosure may be configured in otherorientations to allow a user or patient to view the status of acontainer. The fill indicator 70 may have accompanying indiciaindicating a volume of the pharmaceutical composition in the container.In some examples, the delivery device 20 may have a plurality ofcontainers, with each container receiving the same or differentpharmaceutical composition.

Referring to FIGS. 10A-11 , in another exemplary embodiment, thedelivery device 20 may have a viewing window or fill-indicator display270 which includes a fill-line display indicating the prior tofilling/empty condition, the partially filled/delivered condition, andthe filled condition. In this manner, a technician can readily identifyhow much, if any, medicament is provided within the container 306. Inthis configuration, indicia on the housing of the delivery device 20 mayalign with the visual identifier of the container to indicate to a userand/or patient the amount of medicament within the container 306 at agiven time.

Referring to FIGS. 15-17 , in another exemplary embodiment, a connector312 includes the visual identifier 308, with the connector 312 beingattachable to a portion of the container 306. In one embodiment, theconnector 312 is attachable to a sealed edge of the container 306. Theconnector 312 may include an indicator clip which can be secured to aportion of the container 306, such as along a container seam. Theconnector 312 may be movable relative to the viewing window 304 of ahousing 302 of a delivery device 300 between an empty position (FIG. 15), in which the container 306 is empty, and a full position (FIG. 17 ),in which the container 306 is full. Movement within the viewing window304 indicates to a user the content volume of the container 306.

Referring again to FIGS. 15 and 17 , in one embodiment, as the container306 is filled, it expands. In one embodiment, because the top of thecontainer 306 is constrained by the top of the housing 302, thecontainer 306 is forced to expand downward as it is filled. As thecontainer 306 is filled, the connector 312 moves downward, and itsmovement is visible in the viewing window 304 of the housing 302.

Referring to FIGS. 18-19 , in another exemplary embodiment, a visualidentifier 308 is disposed within the housing 302 between the container306 and a deformable material 320. The deformable material 320 serves tosupport the container 306 and to provide a consistent initial position,original state, or empty position, for the visual identifier 308, asshown in FIG. 18 .

In one embodiment, the deformable material is a foam, such as a lowdensity foam. As the container 306 is filled with medicament, the weightof the container 306 compresses the deformable material 320. A visualidentifier 308 in the form of a rigid component 322, such as a plasticstiffener, may be disposed within the housing 302 between the container306 and the deformable material 320 such that the visual identifier 308is viewable through a portion of the viewing window 304, such as duringfilling of the container 306 to allow for visualization of the volume ofcontent within the container 306 through the viewing window 304. Therigid component 322 is movable relative to the viewing window 304 of ahousing 302 of a delivery device 300 between an empty position (FIG. 18), in which the container 306 is empty, and a full position (FIG. 19 ),in which the container 306 is full. As the container 306 is filled, thecontainer 306 expands. In one embodiment, because the top of thecontainer 306 is constrained by the top of the housing 302, e.g., asshown in FIGS. 18 and 19 , the container 306 is forced to expanddownward as it is filled. As the container 306 is filled, the rigidcomponent 322 moves downward, and its movement is visible in the viewingwindow 304 of the housing 302. As the container 306 delivers themedicament, the container 306 shrinks and the deformable material 320expands thereby moving the rigid component 322 upward. With the rigidcomponent 322 in the empty position (FIG. 18 ), the deformable material320 is in an original state, and with the rigid component 322 in thefull position (FIG. 19 ), the deformable material 320 is compressed.

Referring to FIGS. 20-23 , in another exemplary embodiment, a visualidentifier 308 includes a deflectable member 330. In one embodiment, thevisual identifier 308 is a flexible cantilever such as a long stiffener.In one embodiment, a deflectable member 330 allows for a greater rangeof movement of the visual identifier 308 relative to the viewing window304 of the housing 302 of the delivery device 300. Referring to FIGS. 20and 21 , a deflectable member 330 of the present disclosure is movablerelative to the viewing window 304 of a housing 302 of a delivery device300 between an empty position (FIG. 20 ), in which the container 306 isempty, and a full position (FIG. 21 ), in which the container 306 isfull. As the container 306 is filled, the container 306 expands. In oneembodiment, because the top of the container 306 is constrained by thetop of the housing 302, e.g., as shown in FIGS. 20 and 21 , thecontainer 306 is forced to expand downward as it is filled. As thecontainer 306 is filled, the deflectable member 330 moves downward, andits movement is visible in the viewing window 304 of the housing 302. Asthe container 306 is filled with the medicament, the container 306expands and deflects one end, e.g., a first end 332, of the deflectablemember 330 downward. In one embodiment, as the container 306 deliversthe medicament, the container 306 shrinks and the one end, e.g., thefirst end 332, of the deflectable member 330 returns to its originalposition. As shown in FIGS. 20-21 , the first end 332 of the deflectablemember 330 may be visible through the viewing window 304 to indicate toa user the volume of contents within the container 306.

Referring to FIGS. 22 and 23 , in one embodiment, the deflectable member330 may be secured to the container 306, such as at one end of thedeflectable member 330, via an adhesive 334. In other embodiments,similar fastening mechanisms may be used to secure the deflectablemember 330 to the container 306.

In other configurations, it is anticipated herein that the visualidentifier may be in the form of a viewable pattern. Optionally, amagnifying lens may be provided over the visual identifier and/or thevisualizing window to provide for enhanced viewablility of the visualidentifier.

With reference to FIGS. 2-3 , the delivery device 20 may also have atleast one indicator 90. The at least one indicator 90 may be a visualindicator, an audible indicator, a tactile indicator, or a combinationthereof. For example, the at least one indicator 90 may be a speaker,such as, without limitation, a piezo-buzzer, and/or a light, such as alight-emitting diode (LED) light. The LED may be a multi-color LED. Insome examples, a plurality of LEDs of same or different colors may beprovided. With reference to FIG. 12 , the LED may be provided on a topsurface of the delivery device 20 for easy viewing by the patient. TheLED may be configured to walk-through certain drug delivery steps and/orerror messaging for the benefit of the patient by altering the color ofthe LED, the rapidity at which the LED flashes, or through a transitionof flashing and constant LED signals. The LED may be configured toindicate errors with the device, such as improper attachment to thepatient, occlusions in the drug expulsion mechanism, low batterywarnings, and the like. The LED may also be configured to indicate tothe patient an end-of-dose indicator. Optionally, multiple indicators90, such as multiple LEDs may be provided on opposing sides of thedelivery device 20 to optimize viewing from multiple directions.

In other examples, the at least one indicator 90 is a display screen.The at least one indicator 90 may provide information about a status ofthe delivery device 20, such as, without limitation, when the deliverydevice 20 is delivering the pharmaceutical composition to the patient,when the delivery of the pharmaceutical agent is completed, and/orwhether the delivery device 20 is paired with the notification device30. Various other information about the status of the delivery device 20may be provided by the at least one indicator 90. The at least oneindicator 90 may be powered by a power source (not shown), such as abattery.

In other configurations, it is anticipated herein that an LED may alsobe provided in viewing window 200 to impart enhanced viewing of thevisual indicator and/or to provide a status of the delivery device 20itself.

The delivery device 20 may have one or more user input devices 100, suchas one or more buttons. The one or more user input devices 100 can beused for configuring the delivery device 20, such as, withoutlimitation, wirelessly connecting the delivery device 20 with thenotification device 30 and/or activating the delivery device 20. Incertain configurations, the delivery device 20 may include one or moreinput devices 100, such as one or more buttons that are translucent orat least partially translucent such that an indicator 90, such as an LEDis viewable through the translucent or partially translucent buttons.

The delivery device 20 has wireless communication circuitry 110, suchas, without limitation, a Wi-Fi module, a Bluetooth™ module, a nearfield communication (NFC) module, or other wireless communicationcircuitry, such depicted with reference to FIG. 9 . The wirelesscommunication circuitry 110 is configured to allow the delivery device20 to communicate with one or more other electronic devices, such as thenotification device 30 or other device through a wireless connection.The wireless connection may be any Wi-Fi connection, Bluetooth™connection, NFC connection, or other wireless connection. The wirelesscommunication circuitry 110 may be configured for automatically pairingwith one or more other electronic devices within the range of a wirelesssignal sent by the delivery device 20.

In some examples, the wireless communication circuitry 110 is configuredto provide one-way communication with one or more other electronicdevices, such as the notification device 30 or other device. The one-waycommunication with one or more electronic devices may includecommunicating information regarding at least one property of thedelivery device 20, such as, without limitation, the delivery status ofthe delivery device 20, fill volume of the delivery device 20, whetherthe delivery device 20 is paired with one or more other electronicdevices, and/or the type of pharmaceutical composition being deliveredto the patient.

In other examples, the wireless communication circuitry 110 isconfigured to provide two-way communication with one or more otherelectronic devices, such as the notification device 30 or other device.The two-way communication with one or more electronic devices mayinclude, without limitation, communicating information regarding atleast one property of the delivery device 20, such as, withoutlimitation, the delivery status of the delivery device 20, fill volumeof the delivery device 20, whether the delivery device 20 is paired withone or more other electronic devices, and/or the type of pharmaceuticalcomposition being delivered to the patient, and receiving informationfrom the one or more electronic devices. In some examples, receivinginformation from one or more electronic devices may include controlsignals for controlling at least one aspect of the delivery device 20,such as the delivery status of the delivery device 20.

Notification Device

With reference to FIG. 4 , one exemplary and non-limiting embodiment ofthe notification device 30 is shown. In the examples shown in FIG. 4 ,the notification device 30 is embodied as a wristband having a strapportion 120 and a display portion 130. The strap portion 120 isconfigured for being secured around a user's wrist W. In other examples,the notification device 30 may be a keychain, a pendant, a patch, aring, a necklace, or any other wearable or non-wearable deviceconfigured for wirelessly communicating with the delivery device 20 tocommunicate information regarding at least one property of the deliverydevice 20, such as, without limitation, the delivery status of thedelivery device 20, fill volume of the delivery device 20, whether thedelivery device 20 is paired with the notification device 30, and/or thetype of pharmaceutical composition being delivered to the patient.

With reference to FIGS. 5A-5D, the display portion 130 of thenotification device 30 has at least one indicator 140. The at least oneindicator 140 may be a visual indicator, an audible indicator, a tactileindicator, or a combination thereof. For example, the at least oneindicator 140 may be a speaker, such as, without limitation, apiezo-buzzer, and/or a light, such as a light-emitting diode (LED)light. The LED may be a multi-color LED. In some examples, a pluralityof LEDs of same or different colors may be provided. For example, inFIG. 5A, the notification device 30 is shown in a pre-use initialconfiguration. In FIG. 5B, the notification device 30 is activated and afirst LED is visible and illuminated and extends about a first portionof the display indicating a first period of activation of the deliverydevice 20, such as delivery of a first pre-determined amount ofmedicament. In FIG. 5C, a second LED is visible and illuminated andextends about a second portion of the display indicating a secondportion of activation of the delivery device 20, such as delivery of asecond pre-determined amount of medicament. In FIG. 5D, a third LED isvisible and illuminated and extends about a third portion of the displayindicating a third portion of activation of the delivery device 20, suchas delivery of a third pre-determined amount of medicament.

In other examples, the at least one indicator 140 is a display screen.The at least one indicator 140 may provide information about a status ofthe delivery device 20 and/or the notification device 30, such as,without limitation, when the delivery device 20 is delivering thepharmaceutical composition to the patient, when the delivery of thepharmaceutical agent is completed, whether the delivery device 20 ispaired with the notification device 30, and/or the type ofpharmaceutical composition being delivered to the patient. Various otherinformation about the status of the delivery device 20 and/or thenotification device 30 may be provided by the at least one indicator140. The at least one indicator 140 may be powered by a power source(not shown), such as a battery.

The notification device 30 may have one or more user input devices 150,such as one or more buttons. The one or more user input devices 150 canbe used for configuring the notification device 30, such as, withoutlimitation, wirelessly connecting the notification device 30 with thedelivery device 20 and/or activating the notification device 30.

The notification device 30 has wireless communication circuitry 160,such as a Wi-Fi module, a Bluetooth™ module, a near field communication(NFC) module, or other wireless communication circuitry. The wirelesscommunication circuitry 160 is configured to allow the notificationdevice 30 to communicate with one or more other electronic devices, suchas the delivery device 20 or other device through a wireless connection.The wireless connection may be any Wi-Fi connection, Bluetooth™connection, NFC connection, or other wireless connection. The wirelesscommunication circuitry 160 may be configured for automatically pairingwith one or more other electronic devices within the range of a wirelesssignal sent by the notification device 30.

In some examples, the wireless communication circuitry 160 is configuredto provide one-way communication with one or more other electronicdevices, such as the delivery device 20 or other device. The one-waycommunication with one or more electronic devices may include receivinginformation regarding at least one property of the delivery device 20,such as, without limitation, the delivery status of the delivery device20, fill volume of the delivery device 20, whether the notificationdevice 30 is paired with the delivery device 20, etc. In other examples,the wireless communication circuitry 160 is configured to providetwo-way communication with one or more other electronic devices, such asthe delivery device 20 or other device. The two-way communication withone or more electronic devices may include receiving informationregarding at least one property of the delivery device 20 and sendinginformation to the delivery device 20. In some examples, sendinginformation to the delivery device 20 may include sending controlsignals for controlling at least one aspect of the delivery device 20,such as the delivery status of the delivery device 20.

In one or more examples, the notification device 30 may be connected toanother electronic device (e.g., phone, laptop, tablet, etc.) through awireless connection in order to control the notification device 30and/or send status information about the notification device 30 and/orthe delivery device 20.

In some examples, the notification device 30 may be mechanically and/orelectrically connected with the delivery device 20 by a wiredconnection.

Method of Using the Administration System

Having described the structure of the administration system 10, a methodof using the administration system 10 to deliver a dose ofpharmaceutical composition to the patient will now be described withreference to FIGS. 6A-9 .

Setup

A patient or the medical practitioner removes the delivery device 20from packaging 170. In some examples, removal of the delivery device 20from the packaging may automatically activate the delivery device 20 toa ready state. In other examples, the delivery device 20 may beactivated after removal from packaging by pressing one or more userinput devices 100, 150. In some examples, the patient or the medicalpractitioner may set a target dose of the pharmaceutical composition tobe delivered to the patient.

The delivery device 20 and the notification device 30 are initially inan “off” state. The patient or the medical practitioner activates thedelivery device 20 and the notification device 30 by actuating the oneor more user input devices 100, 150, respectively, such as by pressingone or more buttons for a predetermined amount of time, such asapproximately 1 second. The at least one indicator 90 on the deliverydevice 20 may indicate that the delivery device 20 has been turned on.For example, the LED light on the delivery device 20 may flash yellow ata predetermined interval such as, every 1 second, and the speaker mayplay an activation tone. Similarly, at least one indicator 140 on thenotification device 30 may indicate that the notification device 30 hasbeen turned on. For example, the LED light on the notification device 30may flash green at a predetermined interval such as, every 0.5 seconds,and the speaker may play an activation tone.

Pairing

Upon activation, the delivery device 20 and the notification device 30may activate the respective wireless communication circuitry 110, 160 toautomatically pair the delivery device 20 to the notification device 30.The wireless communication circuitry 110, 160 may be active for apredetermined length of time, such as approximately 75 seconds, duringwhich the notification device 30 that is within the range of thedelivery device 20 will be paired with the delivery device 20. In someexamples, the notification device 30 may use an out-of-band (OOB) methodof pairing. When paired, the at least one indicator 90 on the deliverydevice 20 and the at least one indicator 140 on the notification device30 may indicate a successful pairing of the notification device 30 withthe delivery device 20. For example, the LED on the delivery device 20may be turned off, while the LED light on the notification device 30 mayflash green at a predetermined interval such as, every 0.5 seconds. Ifthe notification device 30 and the delivery device 20 are not pairedwithin the predetermined period, the notification device 30 and thedelivery device 20 go into a standby mode.

Filling and Priming

The delivery device 20 may be filled and primed with the pharmaceuticalcomposition. Once a desired dose of the pharmaceutical composition isfilled and the delivery device 20 is primed, the at least one indicator90 on the delivery device 20 and the at least one indicator 140 on thenotification device 30 may indicate that the delivery device 20 is readyfor use. In certain embodiments, and with specific reference to FIGS.10A-10C, the container of the pharmaceutical composition 306 may be areservoir bag which is at least partially visible through a viewingwindow 280 disposed in at least a portion of the housing of the deliverydevice 20. For example, the container 306 may be made from a flexiblematerial which expands in size as a fluid medicament is filled into thecontainer 306. Optionally, the container 306 may have a visual indicatorintegrally formed therewith. In one embodiment, the container 306 may bemade of a material having a visually distinct color, such as afluorescent green material, such that the positioning of the container306 within the viewing window 280 is readily identifiable. In otherconfigurations, a visual identifier may be stamped or painted onto atleast a portion of the container 306. The visual identifier may be inthe form of a line or other distinct patterning, or alternatively, theentire container 306 may include the visual identifier, such as anoverall color of the container 306. Depending on the particular natureof the medicament to be provided into the container 306, it may bedesirable to provide a container 306 that is light-impermeable.

As shown specifically in FIGS. 10A-10C, the delivery device 20 may havea fill-indicator display 270 which includes a fill-line displayindicating the prior to filling/empty condition, the partiallyfilled/delivered condition, and the filled condition of the container306 disposed within the delivery device 20. In this configuration, thepositioning of the reservoir bag 290 within the viewing window 280 cancoincide with at least one indicator of the fill-indicator display 270to indicate a state of fill of the device during both filling anddelivery of a medicament. As the container 306 includes areadily-identifiable visual indicator, such as a horizontal line, aposition of the container, such as a reservoir bag, can align with anindicator of the fill-indicator display 270 to communicate to a user theamount of medicament disposed within the container 306 during thefilling or emptying process.

As shown in the first step of FIG. 10A, in the prior to filling (orfully emptied) condition, the visual identifier of the container 306 isaligned with the “empty” indicator of the fill-indicator display 270,conveying to the user that there is no appreciable medicament within thecontainer 306. As shown in the second step of FIG. 10B, in the partiallyfilled (or partially delivered) condition, the visual identifier of thecontainer 306 is aligned with the intermediate indicator of thefill-indicator display 270, conveying to the user that there is anidentified amount of medicament within the container 306. As shown inthe third step of FIG. 10C, in the filled condition, the visualidentifier of the container 306, such as a reservoir bag, is alignedwith the “full” indicator of the fill-indicator display 270, conveyingto the user that the device has a full dose of medicament within thecontainer 306. It will also be appreciated herein that if the entirecontainer 306 functions as the visual identifier, such as in the case inwhich the container 306 has an overall contrasting color, then thepositioning of the container 306 itself with respect to the individualindicators of the fill-indicator display 270 will convey the amount ofmedicament within the container 306 to the user.

In some examples, it may be desired that the delivery of the dose ofpharmaceutical composition be delayed by a predetermined length of time,such as, for example, about 27 hours. In some examples, the fill volumeof the pharmaceutical composition and the preset delay may beconfigurable. The at least one indicator 90 on the delivery device 20and the at least one indicator 140 on the notification device 30 mayindicate the beginning of the delay period. For example, the LED on thenotification device 30 may flash green every second.

With reference to FIGS. 6B-6C, the filled and primed delivery device 20is applied to the patient's body B by removing a protective covering 180from the dermal pad 50 to expose the injection needle 60 and apply thedermal pad 50 to the patient's skin. The patient or the medicalpractitioner may activate the injection assembly to deploy the injectionneedle 60. The at least one indicator 90 on the delivery device 20 andthe at least one indicator 140 on the notification device 30 mayindicate when the injection needle 60 has been inserted into thepatient's body.

Delivery

Upon priming and filling the delivery device 20 and attaching thedelivery device 20 to the patient's body, the delivery device 20 willstart the delivery of the pharmaceutical composition upon expiration ofthe delay period. Once the delivery process starts, the at least oneindicator 90 on the delivery device 20 and the at least one indicator140 on the notification device 30 may indicate that the delivery is inprogress. For example, the LED on the notification device 30 may flashgreen every 0.5 seconds. The buzzer on the notification device 30 mayindicate the start of the delivery procedure by producing a deliverytone. The delivery procedure may be paused when one or more of the userinput devices 100 on the delivery device 20 are actuated. In someexamples, the delivery procedure may be paused when one or more of theuser input devices 150 on the notification device 30 are actuated. Thedelivery procedure may be resumed by actuating the one or more of theuser input devices 100 on the delivery device 20, and/or one or more ofthe user input devices 150 on the notification device 30. The at leastone indicator 90 on the delivery device 20 and the at least oneindicator 140 on the notification device 30 may indicate that thedelivery is completed. For example, the LED on the notification device30 may be solid green. The delivery device 20 and the notificationdevice 30 may automatically deactivate after the delivery is completed.When the delivery is completed, the delivery device 20 may be removedfrom the patient's body and discarded. The notification device 30 may bereusable with another delivery device 20, or it may be discarded after asingle use.

In some examples, the at least one indicator 90 on the delivery device20 and the at least one indicator 140 on the notification device 30 maybe used to indicate an error message during administration of thepharmaceutical composition. In some examples, the LED on the deliverydevice 20 and/or the notification device 30 may flash red, and/or thespeaker/buzzer on the delivery device 20 and/or the notification device30 may sound a warning tone to instruct the patient to contact themedical practitioner.

In some examples, the notification device 30 may communicate, usingwireless communication, the status of the notification device 30 and/orthe delivery device 20 to a remote device, such as, without limitation,a computer, a laptop, or a smartphone (relay mode). In other examples,the notification device 30 may communicate, using wirelesscommunication, the status of the notification device 30 and/or thedelivery device 20 to the cloud (cell mode).

Although the invention has been described in detail for the purpose ofillustration based on what is currently considered to be the mostpractical and preferred embodiments, it is to be understood that suchdetail is solely for that purpose and that the invention is not limitedto the disclosed embodiments, but, on the contrary, is intended to covermodifications and equivalent arrangements that are within the spirit andscope of the appended claims. For example, it is to be understood thatthe present invention contemplates that, to the extent possible, one ormore features of any embodiment can be combined with one or morefeatures of any other embodiment.

The invention claimed is:
 1. A delivery apparatus configured to delivera dose of a medicament to a patient, the delivery apparatus comprising:a delivery device, comprising: a housing including a viewing window, aflexible container disposed within the housing and for storing themedicament therein, and a visual identifier aligned with a portion ofthe viewing window, wherein a position of the visual identifier relativeto the viewing window is dependent on a volume of the medicament withinthe container; wherein the visual identifier is movable relative to theviewing window between an empty position, in which the container isempty of medicament, and a full position, in which the container is atleast partially full with medicament; and a notification device incommunication with the delivery device, the notification deviceconfigured to communicate information about a status of at least oneproperty of the delivery device.
 2. The delivery apparatus of claim 1,wherein the delivery device comprises a needle movable between aretracted position, in which the needle does not protrude outside thehousing, and an extended position, in which the needle protrudes outsidethe housing, the delivery device configured to move the needle betweenthe retracted position and the extended position, with the deliverydevice retracting the needle to the retracted position after the dose ofthe medicament to the patient is delivered.
 3. The delivery apparatus ofclaim 1, wherein the visual identifier comprises a connector that isattachable to a portion of the container.
 4. The delivery apparatus ofclaim 3, wherein the connector is attachable to a sealed edge of thecontainer.
 5. The delivery apparatus of claim 3, wherein the connectorcomprises an indicator clip.
 6. The delivery apparatus of claim 1,wherein the container is a reservoir bag and the visual identifier is acolored reservoir bag made of a material having a visually distinctcolor from the housing.
 7. The delivery apparatus of claim 6, whereinwhen the colored reservoir bag is empty, a color band of the reservoirbag is shown through the viewing window and appears as a straight ornear straight line located adjacent an empty indicator line, and whereinas the colored reservoir bag is filled and expands, a width of thecolored reservoir bag is increased and a color band of the reservoir bagis shown through the viewing window and appears as a broad, wide bandthat expands to a point adjacent a full indicator line.
 8. The deliveryapparatus of claim 1, wherein the container is a reservoir bag and thevisual identifier is a portion of the reservoir bag.
 9. The deliveryapparatus of claim 8, wherein the visual identifier comprises a line ordistinct patterning stamped or painted onto the reservoir bag.
 10. Thedelivery apparatus of claim 8, wherein the visual identifier comprises acolor band added to the reservoir bag, the color band added by padprinting, roll printing, or adhesive patch attachment.
 11. The deliveryapparatus of claim 10, wherein the visual identifier comprises adeflectable member, and wherein as the container is filled with themedicament, the container expands and deflects one end of thedeflectable member downward.
 12. The delivery apparatus of claim 11,wherein as the container delivers the medicament, the container shrinksand the one end of the deflectable member returns to its originalposition.
 13. The delivery apparatus of claim 1, wherein the housingcomprises a fill-indicator display adjacent the viewing window.
 14. Thedelivery apparatus of claim 13, wherein the visual identifier alignswith a portion of the fill-indicator display to identify an amount ofmedicament within the container.
 16. The delivery apparatus of claim 1,wherein the viewing window is located in a sidewall of the housing. 17.The delivery apparatus of claim 1, wherein the delivery device is awearable automatic injector removably attachable to a skin surface ofthe patient.
 18. The delivery apparatus of claim 17, wherein thedelivery device includes at least one indicator for communicating acondition of the delivery device to the patient.
 19. The deliveryapparatus of claim 1, wherein the notification device is a wristband.20. The delivery apparatus of claim 1, wherein the notification deviceis in passive one-way communication with the delivery device and whereinthe notification device displays a status of at least one property ofthe delivery device.